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Poster lunch

1186 - Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study (519P)


18 Nov 2017


Poster lunch


Hiroji Uemura


Annals of Oncology (2017) 28 (suppl_10): x155-x165. 10.1093/annonc/mdx676


H. Uemura1, T. Kosaka2, M. Sumitomo3, K. Harada4, M. Sugimoto5, N. Hayashi6, K. Yoshimura7, S. Fukasawa8, E.B. Ecstein-Fraisse9, Y. Sunaga10, M. Oya2

Author affiliations

  • 1 Department Of Urology/renal Transplantation, Yokohama City University Medical Center, 232-0024 - Yokohama/JP
  • 2 Department Of Urology, Keio University Hospital, Tokyo/JP
  • 3 Department Of Urology, Aichi Medical University Hospital, Aichi/JP
  • 4 Department Of Urology, Kobe University Hospital, Kobe/JP
  • 5 Department Of Urology, Kagawa University Hospital, Kagawa/JP
  • 6 Department Of Urology, Yokohama City University Hospital, Yokohama/JP
  • 7 Department Of Urology, Kindai University Hospital, Osaka/JP
  • 8 Department Of Urology/prostate Cancer, Chiba Cancer Center, Chiba/JP
  • 9 Medical, Sanofi France, Paris/FR
  • 10 Biostatistics & Programming, Sanofi Japan, Tokyo/JP


Abstract 1186


Pegfilgrastim (PEG) is used for chemotherapy-induced febrile neutropenia (FN) prophylaxis. FN was observed in 54.5% of patients (pts) who received cabazitaxel (CBZ) 25 mg/m2 in a Japanese phase I study (NCT01324583). This phase 2 study assessed the efficacy and safety of prophylactic use of PEG in Japanese pts with metastatic castration-resistant prostate cancer (mCRPC) treated with CBZ plus prednisolone (P).


Pts previously treated with docetaxel received CBZ 25 mg/m2 Q3W + P 10 mg daily (maximum 10 cycles). PEG was administered on day 2 in the first and subsequent cycles. The primary endpoint was incidence of FN (absolute neutrophil count [ANC]  38.3 °C or sustained temperature of ≥ 38 °C for >1 h) in cycle 1. Decrease (≥50%) in PSA, time-to-PSA progression, and other safety parameters were assessed.


Twenty-one pts (median age 70 years, ECOG-PS 0 or 1 [100%]) were enrolled; 61.9% had prior enzalutamide and 47.6% had prior abiraterone. The median number of cycles of treatment was 7.0; 9 (42.9%) pts completed 10 cycles; 9 (42.9%) discontinued because of disease progression and 3 (14.3%) discontinued because of adverse events. The median relative dose intensity for CBZ was 67.4%. Two (9.5%) pts presented with FN (95% confidence interval [CI], 1.17–30.38) in cycle 1 only. The median ANC nadir was 68.0/mm3 (range, 0–1740/mm3), median days to nadir was 8.0 (range, 7–9) and days to recovery was 4.0 (range, 3–9). Grade 3/4 treatment-emergent adverse events were observed in 21 (100%) pts (Table). There were no toxicity-related deaths. PSA response was observed in 6 (28.6%) pts (95% CI, 11.28–52.18) and the median time to PSA progression was 182 days (95% CI, 71–255).Table: 519P

Grade 3/4 treatment-emergent adverse events. Number of patients = 21.

Grade 3/4 TEAE (≥ 5%)n (%)
Neutropenia20 (95.2)
Thrombocytopenia5 (23.8)
Leukopenia3 (14.3)
Febrile neutropenia2 (9.5)
Decreased appetite2 (9.5)


CBZ plus P with prophylactic use of PEG was well tolerated in Japanese mCRPC pts.

Clinical trial identification

NCT 02441894.

Legal entity responsible for the study

Sanofi K. K.


Sanofi K. K.


H. Uemura: Consultancy fees from Janssen, Astellas, Takeda, Bayer, Daiichi Sankyo; lecture fees from AstraZeneca, Sanofi, Fujifilm, Kyowa Hakko Kirin, Kissei. M. Sumitomo: Consultancy fees from Sanofi, Janssen, Ono, Pfizer, Takeda, Kissei; lecture fees from Sanofi, Pfizer, Takeda, AstraZeneca; research funding from Ono, Sanofi, Astellas, AstraZeneca, Takeda. M. Sugimoto: Manuscript writing/editing fees from Janssen, Astellas, Takeda, AstraZeneca. E.B. Ecstein-Fraisse: Employee of Sanofi. Y. Sunaga: Stock ownership and employee of Sanofi. M. Oya: Consultancy fees from Astellas.; lecture fees from Astellas, Janssen, AstraZeneca, Sanofi, Takeda; research funding from Astellas, Takeda.

All other authors have declared no conflicts of interest.

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